BEUDAMED
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    RADKOR TS10-B

    FDA 510(k)
    FDA Class 2 ·Radiology

    8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Medical Radiation Dosimetry System microSTARii

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATTUNE CR FB INSRT SZ 6 5MM

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·June 24, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 2, 2010

    MATRISTEM SURGICAL MATRIX PSMX

    FDA Adverse Event
    Injury ·ACELL INC.·Product code FTM·December 21, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012